For Life Science Companies

The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.

G = Good

x (variable replaced with Clinical, Manfacturing or Laboratory)

P = Practice

Programs today must be more robust than ever to accommodate all the topics we are all challenged to be knowledgeable in.

As you can see, GxP is used as the acronym that refers to the regulations established by the United States Food and Drug Administration which are published in the Code of Federal Regulations. Sometimes people refer to the "GCPs" which specifically were created as the rules that govern clinical trials vs. product manufacturing (GMPs) or laboratory regulations (GLPs). Together, these rules are known collectively as the "predicate rules" and govern a wide spectrum of regulatory obligations across the diverse life science industries. The predicate rules also provide a standard against which citations can be effectively made when FDA inspections are conducted. Violation of a predicate rule will most likely result in a 483 followed by a warning letter. Got it?

There is just a bit more to help you navigate this important terrain before we delve into why a GxP training / learning program is vital.

When a regulation is cited, the title tells you where it is published. For example: 21 CFR 312.2 means:

21 = Title 21

CFR = Code of Federal Regulations

312.12 (312 = part and 2 = section)

There is a helpful website that you can use to quickly find and research the regulations. As an educator in our industry and as a member of academia, I strongly suggest that you read the regulations that pertain to your roles (and your specific area) even if you have read them before. It is important to stay current! Using this site you can search by regulation or by additional keywords. Go to:

Remember that federal regulations are laws and they establish the obligations with which sponsor organizations, investigators and IRBs/IECs (institutional review boards and independent ethics committees) must be compliant. This includes the requirement to engage personnel who are effectively trained by way of education and/or prior experience and on-going training. An example from the CFR;

21 CFR 312.53 Selecting investigators and monitors.

(a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.

Ibid.

Viii. (2) Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigator showing the education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation.

If you are responsible for a "GxP" task, it is an easy way to say you are performing a regulated process that is most likely linked to a predicate rule or guidance and should be covered by policy and/or specific documented procedures (a.k.a. SOPs) that you are trained in. Some examples include development of a protocol or the monitoring of a clinical study. These are the types of topics that should be covered when designing a "GxP learning program;" procedures and yearly refresher programs should also be covered. The more diverse your organization, the broader your programs should be for enabling personnel to learn what they need to regardless of the professional backgrounds they brought with them when hired. Programs today must be more robust than ever to cover all of the topics required. A brief, yearly refresher course is often not enough.

In the next article I will discuss why a comprehensive learning strategy and program must be in place if today's bio/pharmaceutical organizations are compliant with the regulations and poised for change and transformation. Peter Senge said it best when he described learning organizations as:

"...organizations where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together."

Seeing the "whole" as regards GxP is imperative and will keep your organization on track with existing rules as well as emerging ones. After all, we find ourselves in industry during interesting times of global trial with virtual reach as well as economic and healthcare reform. Do you know what the implications of the current reform legislation are regarding the bio/pharmaceutical industry? That is something for homework. We all need to be ready to transform and respond nimbly to the changes that are coming.

There is more to come in the next article but if you haven't read Senge's book I highly recommend you do especially if GxP training is your responsibility. Senge's work is timeless as we prepare for the challenges and excitement of a new road ahead.

References

Nancie Celini is president and founder of CAB, inc., a technology and training-consulting firm specializing in life science systems and learning programs. Ms. Celini is an experienced system professional and educator with over 30 years of project work spanning document, records and clinical data management systems used during product development. CAB, inc. develops unique organizational learning strategies for renewing and improving information system projects and GxP learning programs. She has developed a diverse number of programs for numerous life science organizations as well as academic and government environments. She began her career with Xerox in 1976 where she helped introduce professional workstations and publishing technology to the pharmaceutical industry. She formed CAB, inc. in 1986, a female, wholly-owned NY corporation and has been actively engaged in independent project work since that time.

Ms. Celini has a diverse education in healthcare information systems and public health and received her MPH from New York Medical College in Valhalla, New York where she currently teaches Healthcare Economics and is earning a doctorate in public health policy. Her work was featured in 2010 on the New York Times Knowledge Network in collaboration with academic colleagues in an on-line course about healthcare economics and reform. She is an experienced classroom and e-learning developer/instructor and is an active member of the Drug Information Association and original U.S. Chair of the Document and Records Management SIAC. She led this volunteer effort in the development of a common reference (taxonomy) model that continues to evolve in hopes to ease the economic and technical burdens on pharmaceutical companies when implementing information repositories systems.

Ms. Celini is an experienced meeting facilitator, instructional designer, international trainer and voice-over professional. She can be reached at: nancie.celini@thinkcab.com for comment and further discussion regarding the intersections of public health, pharmaceutical and regulatory science, policy, technology and learning.

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